Method and morphologically adaptable apparatus for altering the charge distribution upon living membranes with functional stabilization of the membrane physical electrical integrity

ABSTRACT

A method and morphologically adaptable apparatus for altering the charge distribution upon living membranes with functional stabilization of the membrane physical electrical integrity further comprising a method for using quadripolar, circular, center charged, energy balanced magnetic device in a four (4) magnet array of alternating polarity in which the magnetic poles are in multiple planes and are separated by a predetermined distance which provide an effective magnetic sphere of influence on all adjacent poles to suppress the firing of action potentials of mammalian sensory neurons. The method and apparatus further provides a static magnetic device for production of a magnetic field for treatment of various disorders that can be focused at the site of pain or edema to deliver a gradient in the magnetic field to prevent or reduce charge flow. Further there is provided a static magnetic device for production of a magnetic field for treatment of disorders wherein the device provides a static magnetic field such that the focused magnetic field gradient is oriented To be perpendicular to the neuron or membrane charge flow providing maximum deflection of the ion or charge flow.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of co-pending application U.S. Ser. No.11/469,346, filed Aug. 31, 2006 and titled Method and MorphologicallyAdaptable Apparatus for Altering the Charge Distribution Upon LivingMembranes with Functional Stabilization of the Membrane PhysicalElectrical Integrity, which application issued as U.S. Pat. No.7,608,035 on Oct. 27, 2009.

BACKGROUND OF THE DISCLOSURE

1. Field of the Disclosure

The present disclosure relates to magnetic devices for therapeuticapplication for mammals, and more particularly to a static field,quadripolar magnetic treatment device with flux return means and afocusing means to increase the intensity, focus and gradient of thefield for placement against or in proximity to the mammal's body orsurface. The present disclosure further relates to methods of use andconstruction of such magnetic treatment devices for the use of ortreatment of various diseases, complications and disorders such as, butnot limited to, a) acute and chronic pain, b) cardiac dysfunction, c)seizure disorders, d) pain and edema sustained in minor burns, e) insectbites and bee stings, f) potentiation of pharmaceuticals and focusingand for concentrating the drug to the active site, g) protection oftransplant organs, h) treatment of movement disorders, I) control ofedema and pain as well as speed healing following surgical procedures,j) control of pain and sludging of sickled cells in sickle cell disease,k) foot pain and discomfort, l) treatment of pain and otherdysfunctions, m) potentiation of epidural anesthesia and epiduralanalgesia, n) Protection from cell injury and death following cellinsults such as contusion, hypoxic stroke and infection, o) control ofnausea and vomiting associated with pregnancy, motion, and chemotherapy,p) prevention of fertilization of ovum by sperm, q) cumulative traumadisorder in the workplace, r) a magnetic placebo which has no biologicalactivity yet is magnetic and has all characteristics of the authenticdevice except the alternating poles and a significant field gradient.

2. General Background of the Disclosure

Magnetic fields have been applied to the human body for varioustherapeutic purposes for many centuries. For example, magnetic medicaltreatment devices for application against selected portions of the humanbody are disclosed in U.S. Pat. Nos. 3,921,620 and 5,941,902; method andapparatus for suppressing neuron action potential firings are disclosedin U.S. Pat. No. 5,312,321; magnetic plasters for improving circulationare disclosed in U.S. Pat. No. 4,489,711; magnetic fields forstimulation of bone growth are disclosed in U.S. Pat. No. 4,105,017; andmagnetic stimulation of nerve cells has been accomplished with devicessuch as the Cadwell Magneto-Electric Stimulator (MES-10) manufactured byCadwell Laboratories, Inc. of Kennewick, Wash.

Various disease states, tissue and organ malfunction may be the resultof loss of membrane stability and normal permeability. These membranesmay be cellular or intracellular, but in any case represent malfunctionof excitable tissue. This malfunction of excitable tissue may be due toalteration of ion channel function. These various disease and states ofmalfunction may also be related to alteration of receptor sites oragonist sites of enzymes and/or other such dynamic systems within livingorganisms and more particularly the human animal. A great variety ofsymptoms and malfunctions may occur, such as, but not limited to, theabove listed disease and/or disorder states. Many types of ailments,including chronic pain, poor localized blood flow, cerebral edema andcertain seizures and injuries cannot be successfully treated withconventional drug, physical therapy or surgical therapies. Because suchailments are often untreatable with conventional therapies, there is aneed for alternative therapies that relieve these previously untreatableor poorly treatable conditions.

BRIEF SUMMARY OF THE DISCLOSURE

A therapeutic static magnetic treatment device adapted for placement ofmagnetic flux generator poles applied such that the treatment device maybe applied to the mammal as described herein for the variousapplications revealed herein. The device comprises a plurality of staticmagnetic bodies. In one implementation, the device further comprise foursuch magnetic bodies each with a positive and negative pole in each headof the applications, having at least two positive and two negativemagnetic poles substantially in a single plane, the magnetic poles beingoriented to define the four vertices of a quadrilateral shape, the twopositive poles defining opposite diagonal vertices, and the two negativepoles defining opposite diagonal vertices of the quadrilateral shape,each of the magnetic poles being magnetically attracted by theoppositely charged poles and being magnetically repelled by the likecharged poles.

A method and apparatus for altering the charge distribution upon livingmembranes with functional stabilization of the membrane physicalelectrical integrity is disclosed. In exemplary implementations, themethod comprises providing a magnetic device in a four (4) magnet arrayof alternating polarity in which the magnetic poles are separated by apredetermined distance to provide an effective 3-dimensional symmetricmagnetic sphere of influence at the desired site of action from themagnetic fields of all adjacent poles; positioning the device adjacentthe living membranes to suppress the firing of action potentials ofmammalian sensory neurons; wherein the magnet array is altered to focusthe magnetic sphere at different depths.

In another implementation the plurality of magnets may be positioned sothat positive and negative poles are aligned in different planes or awayfrom one another such that the quadrilateral shape lies along a curvedsurface with sufficient strength to achieve the same effective magneticfield at the site of pain or cell damage as similar number of magnets ofdifferent size in a single plane in order to conform the shape of themagnetic field to the position of treatment.

In a further implementation, a morphologically adaptable apparatus foraltering the charge distribution upon living membranes with functionalstabilization of the membrane physical electrical integrity isdisclosed. The apparatus comprises a quadripolar, magnetic device in afour (4) magnet array of alternating polarity in which the magneticpoles are separated by a predetermined distance which will provide aneffective 3-dimensional symmetric magnetic sphere of influence at thedesired site of action from the magnetic fields of all adjacent poles tosuppress the firing of action potentials of mammalian sensory neurons; aconductive fluid flux focusing medium above and around the magneticarray to focus the magnetic field at the site of the membranes; anon-conductive fluid flux return medium below the magnetic array toallow the magnetic field to penetrate the site of the membranes to betreated; and said 3-dimensional symmetric magnetic sphere isperpendicular to the neuron current flow direction.

In another implementation, the method and apparatus has magnets thatvary in size to alter the location of the gradient of the magnetic fieldto set the steepest magnitude of the gradient at the sensory neuron.

In a further implementation, the magnets are oriented to focus themagnetic field at a single point to alter the location of the gradientof the magnetic field at the sensory neuron.

In another implementation, the method and apparatus has a 3-dimensionalsymmetric magnetic field is at least 1.5 mT at the site of the neurons.

In further implementations, the method and apparatus further comprisesthe step of providing a conductive fluid flux focusing medium above andaround the magnetic array to focus the magnetic field at the site of themembranes containing neurons.

In further implementations, the method and apparatus further comprisesthe step of providing a non-conductive fluid flux return medium belowthe magnetic array to allow the magnetic field to penetrate to the siteof the membranes to be treated.

In another exemplary implementation, the flux focusing medium maycomprise a flux focusing ring or other medium and the flux return mediummay comprise a flux return ring or other medium wherein said flux returnring returns at least 50% of magnetic field to membrane site containingneurons.

In a further implementation, the method and apparatus provide a steepfield gradient from the magnet array of alternating polarity at the siteof the neurons. In this implementation of the method, said steep fieldgradient from said magnet array is perpendicular to the direction ofneuron current flow.

The apparatus and method may aid diseases, disorders, complications andconditions that are selected from the group consisting of acute andchronic pain, cardiac disorders, potentiation of pharmaceuticals,movement disorders, potentiation of anesthesia, nausea control, andtrauma.

In exemplary implementations, the magnets can all be replaced byelectromagnets where the magnetic field is obtained by AC runningthrough wires that are wrapped into a coil. the individual magnets arecreated by varying or alternating current conducted through wires in theform of coils that act as electromagnets.

In a further implementation, the method and apparatus provides applyinga symmetric quadripolar, three dimensional magnetic flux field which isfocused and balanced to the human body to stabilize excitable membranesand thereby reduce pain and edema associated with acute injury,inflammation or surgical procedure and to decrease wound healing timewherein the field gradient is steep and at least 1.5 mT at the site ofthe neurons.

In a further implementation, a conductive gel above the magnets to serveas a focusing ring, and a gel below the magnets as a non-conductive gelto allow the magnetic field to pass unimpeded is provided. Theconductive gel above the magnets deflects the field as a means ofincreasing or focusing the magnetic field down in the site of treatment.

In an exemplary implementation, the devices provides a static magneticdevice for production of a magnetic field for treatment of paindisorders, such a device being powered by a particular static magneticfield and having, inter alia, an alternating polarity, quadripolar arraywhich generates a 3 dimensional, steep field gradient (greater than 0.25tm/mm at the site of action) with a homogenous field.

In yet another implementation, the apparatus provides an alternating,quadripolar array in which each of the poles is in the shape of twocones joined at the directrix of the cone with the vertex of the twocones lying in a perpendicular axis of a circular directrix.

In a further implementation, the plurality of magnets are so positionedthat the positive and negative poles are aligned in different planes oraway from one another with sufficient strength to achieve the sameeffective magnetic field at the site of pain or cell damage.

In another implementation, the device provides a conductive gel abovethe magnets to serve as a focusing medium to deflect the field to thesite of pain, and a gel below the magnets as a non-conductive gel toallow the magnetic field to pass unimpeded.

Furthermore, there is taught a method and apparatus for altering thecharge distribution upon living membranes with functional stabilizationof the membrane physical electrical integrity.

In yet another implementation, a device that alters the stability ofexcitable membranes and other charged structures and systems in order totreat ailments in mammals is provided.

A further implementation presents a global technique for controlling thephysical and electrical stability of irritable membranes (either cellwalls or intra-cellular organelles) and altering receptor sites, i.e.enzymes, hormones and/or drugs.

There is further taught a device in which the desired biological effectsare directly related to the magnitude of the gradient in the x, y and zaxis and therefore the magnitude of the vector or summation gradient.

A further implementation provides a device which contains a flux returnmedium on the back surface away from the body surface which is designedto return the magnetic flux thereby altering (increasing) the strengthand gradient without materially altering the center charge symmetry andhomogeneity of the 3 dimensional steep gradient field.

A further implementation of the device provides a flux focusing mediumsurrounding the (static) magnetic poles on the outer perimeter stationedsubstantially midway between the top and bottom of the pole surroundingstatic magnetic poles on the outer perimeter stationed substantiallyabove the magnets on the side away from the site of action to direct themagnetic field flux back toward the site of action to increase the fieldand the field gradient. Attachment means is provided to hold thefocusing medium to the outer perimeter of the poles throughout the totalsupport means.

Another implementation provides a static magnetic pole of like polarityon the outer surface of each of the poles of the focusing magnet suchthat the top of the focusing magnet is oriented to the geometric side ofthe pole, for example such that the axis of two magnets form a 45 to 90degree angle or a 90 to 135 degree angle. The focusing magnet comprisesa static magnetic pole.

In another implementation, a static magnetic pole of like polarity onthe outer surface of the flux focusing ring adjacent to, for example,each of the 4 poles of the device (focusing magnet) such that the end ortop of the focusing magnet is oriented to the geometric side of the polesuch that the axis of the two magnets form a 45 to 90 degree angle. Thefocusing magnet comprises a static magnetic pole. The angle of thefocusing magnet is such that the axis forms a 45 to 90 degree angle onthe body surface side and a 90 to 135 degree angle to the surface awayfrom the body.

In another implementation, one can control the focusing of each magnetwith a smaller and weaker magnet than the primary pole such that thefocusing medium containing magnets can focus and balance the symmetry ofthe therapeutic field.

A further implementation reveals a method of design and manufacture ofan inexpensive, center charged and homogeneous static magnetic fluxmagnet.

In one implementation the plurality of magnet bodies in each devicecomprises four lightweight, intense field static magnets, the staticmagnetic poles being the shape of a cylinder or in a furtherimplementation in the shape of two cones joined at the directrix of thecone with the vertex of the two cones lying in a perpendicular axis ofthe circular directrix such that the vertex of the double cone shapedmagnetic bodies may all be tilted toward the midline ( on the sidefacing the animal body) such that the peak or vertex being pulled towardthe midline will give a more steep field gradient.

In an additional implementation the device contains a flux return mediumon the back surface away from the body surface which is designed toreturn the magnetic flux thereby increasing the strength and gradientwithout altering the center charge symmetry and homogeneity of the 3dimensional steep gradient field.

In a further implementation, a flux focusing medium surrounds, forexample, four static magnetic poles on the outer perimeter stationedmidway between the top and bottom of the pole at the junction of thebase of the two cone shapes which join at the directrix of the cone.

On the outer surface of each of the poles of the disclosure attached tothe flux focusing ring is a small focusing cylindrical magnet orientedto the geometric side of the pole such that the axis of two magnets forma 45 to 90 degree angle (Focusing magnet/Magnet pole=¼ in size). Inanother implementation the containment means may be plastic which coversthe entire implementation. The size of the device is dictated by theapplication, but averages about 1×¼ inches in the round.

In a further implementation, a method of adding a plastic material to apermanent magnet amalgam along with a proprietary silica colloid andcuring the amalgam under the influence of a strong, center chargedhomogenous magnetic field is disclosed.

The accompanying drawings, which are incorporated herein and constitutea part of this specification, illustrate implementations of thedisclosure, and together with the description, serve to explain theprinciples of the disclosure.

Another implementation provides a magnetic device which has theflexibility to treat human cells, while not necessarily lying in asingle plane, but more in adapting to the specific contours of the cellsbeing affected; i.e. to make the device morphologically adaptable in itsmultiple applications.

Definitions

In accordance with the present disclosure and as used herein, thefollowing terms are defined with the following meanings, unlessexplicitly stated otherwise.

The term “mammal” refers to any of various warm-blooded vertebrateanimals including those in the class Mammalia, and includes humans.

The term, “Tesla” refers to a unit of magnetic flux density or magneticfield intensity in the International System of Units equal to themagnitude of the magnetic field vector necessary to produce the force ofone Newton on a charge of one coulomb moving perpendicular to thedirection of the magnetic field vector with a velocity of one meter persecond.

The term, “grease” refers to a thick oil or viscous substance.

The term “gradient” refers to the rate at which a physical quantity,such as temperature or pressure, increases or decreases relative tochange in a given variable, especially distance. The term may also referto a vector having coordinate components that are the partialderivatives of a function with respect to its variables.

The term “summation gradient” refers to the vector sum of the magneticfield from all magnets in the array.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an overall view of an implementation of the magneticdevice.

FIG. 2 illustrates a top view of the magnetic device illustrated in FIG.1.

FIG. 3 illustrates a cross-section view through lines 2-2 of FIG. 2 ofthe magnetic device.

FIG. 4 illustrates an overall view of an alternative implementation ofthe magnetic device illustrated in FIG. 1.

FIG. 5 illustrates a top view of FIG. 4 thereof.

FIG. 6 illustrates a cross-section view through lines 4-4 in FIG. 5 ofthe alternative implementation of the improved magnetic device.

FIG. 7 illustrates an overall view of a second implementation of themagnetic device illustrated in FIG. 1.

FIG. 8 illustrates a third alternative implementation of the magneticdevice illustrated in FIG. 1.

FIG. 9 illustrates a top of the device illustrated in FIG. 8.

FIG. 10 illustrates a cross-section view along lines 9-9 in FIG. 9.

FIG. 11 illustrates a fourth alternative implementation of the magneticdevice illustrated in FIG. 8.

FIG. 12 illustrates a top of the device illustrated in FIG. 11.

FIG. 13 illustrates a cross-section view along lines 11-11 in FIG. 12.

FIG. 14 illustrates a fifth alternative implementation of the magneticdevice illustrated in FIG. 1.

FIGS. 15 through 19 illustrate cross-section views of the magneticdevice illustrated in FIG. 14.

FIG. 20 illustrates a magnetic device where the magnets are all the samesize and in the same plane.

FIG. 21 illustrates the magnitude of the magnetic field of the device inFIG. 20.

FIG. 22 illustrates the gradient of the device in FIG. 20.

FIG. 23 illustrates an overview of an implementation of the magneticdevice.

FIG. 24 illustrates the magnitude of the magnetic field of the device inFIG. 22.

FIG. 25 illustrates the gradient of the device in FIG. 22.

DETAILED DESCRIPTION

Before explaining the present disclosure in detail, it is to beunderstood that the disclosure is not limited to the particularimplementations and that it can be practiced or carried out in variousways.

Device

Devices are taught with magnetic poles of alternating polarity directedtoward the site of membranes or neurons to be treated in which the polesmay all be tilted toward (or away from) the midline (on the side facingthe mammal body) such that the peak or vertex position toward themidline will vary (or sharpen the angle of ) the field gradient. Thereare taught methods which provide devices with magnetic poles ofalternating polarity directed toward the site of membranes or neurons tobe treated in which the shape of the magnetic bodies can be changed byconstructing any number of the magnets to be of different size,magnetization, or orientation attached to the flux return ring whichfaces away from the mammal body. The vertex may be tilted toward themidline (on the side facing the mammal body) such that the peak orvertex position toward the midline will alter the field gradient.

Improved Morphologically Adaptable Implementations

Reference is now made to several implementations of the device that willbe discussed below in detail in reference to FIGS. 1 through 19. Ingeneral, one or more variations to the current parallelogram withattendant magnetic pole modifications will demonstrate the range (polestrength and distance) of (a) alternative single plane configurations;(b) an electromagnetic configuration; (c) a saddle configuration; (d) atwo (2) plane configuration; (e) the use of a gel as a replacement forand/or compliment to the focusing ring; and (f) a countercurrent optionto the mini-MagnaBlocs to be included in the magnetic treatment device(U.S. Pat. No. 6,461,288) as an alternative method for drugpotentiation.

In the implementations, there is provided an effective magnetic field atthe site of pain. Electromagnetic fields benefit from a concept known assuperposition. A simple example can illustrate this with light which isan electromagnetic field. If one would shine two identical flashlightson a spot the field strength is the same as if one used a flashlightwith twice the illumination. If one uses one that is 50% and anotherthat is 150% of the illumination of the original two the spot still isthe same field intensity.

The magnetic arrays taught in this patent can be used wherever thearrays described in U.S. Pat. Nos. 5,312,321 and 6,461,288 can be used.

Thus, in the disclosed implementations any two opposing magnets can bemoved away from the other two as long as there is an adjustment theirmagnitude to make the “spot” at the point of action the same. If onemoves two in a plane above the other two, the two in the high plane needto be stronger. If one moves two in the plane further away from thecenter, the two that are further away need to be stronger.

In other implementations, the magnets can all be replaced byelectromagnets where the magnetic field is obtained by AC runningthrough wires that are wrapped into a coil. Usually this coil is wrappedon a piece of ferromagnetic material and the most convenient form is atoroid (dough nut shape) because the field through the center of thetoroid acts up and down through the hole giving the action of a regularpermanent magnet. Winding the coil in a cylindrical shape either arounda core or simply arranged as a cylinder can also provide the positiveand negative magnetic poles at the ends of the cylinder. Theimplementation of the “saddle” is for wrists, ankles, etc. where it willbe convenient to bend two of the magnets respective to the plane of theother two to create the equivalent field at the site of action.

The focusing ring can be replaced by a conductive gel above the magnets.The gel below the magnets is preferentially non-conducting to allow thefield to pass unimpeded. A gel above the magnets (away form the site ofaction) will deflect the field and can be molded like the focusing ring.It is foreseen that the type of gel to be most effective would be a gelproduct of the type offered by McMaster-Carr, disclosed in the 2004company catalog 110.

In these implementations, the magnets can also be held in the sameceramic or plastic housing. The magnets may look like one magnet whenthis is done, but each magnet has a unique north and south pole. Ifmagnets are not separated in space as required by the disclosure, onecannot maintain the quadripolar arrangement. Even though the magnets arein one “structure,” they are still separate magnets and the magnets cantake all the configurations noted above.

Turning now to the Figures which illustrate the morphologicallyadaptable implementations, FIGS. 1 though 9 illustrate exemplaryimplementations of the magnetic device 500 illustrated in FIG. 1. Asillustrated first in FIG. 1, magnetic device 500 includes a plurality ofat least four magnetic bodies 502, 504, 506, 508, that are oriented andcontained within a housing 510 that can be maneuvered manually withoutupsetting the arrangement and orientation of the magnetic bodies 502through 508. In general, and depending on the specific implementationwhich will be discussed below, each of the magnetic bodies comprises acylindrical, center-charged permanent magnet. The magnets may or may notbe, depending on the implementation, of equal strength, and set at equalplanes within the housing 510. Magnets across from one another willalways have the same polarity. In one implementation magnets oppositeone another are of equal strength; for example 502 and 506 will have thesame strength and in another implementation magnets 502 and 506 may havedifferent strengths. Each of the magnetic bodies are arranged so thatthere are opposing positive and negative magnetic poles. When themagnets are in a flat plane they will not be of equal strength. In adifferent implementation with magnets of equal strength, the magnetswill not be in a flat plane. Collectively, the four magnetic bodiesdefine a magnetic octapole.

Turning first to FIG. 1, there is provided the magnetic device 500having four magnetic bodies 502, 504, 506, and 508. The four magneticbodies are contained and held fixed within a housing 510. In thisimplementation, as seen in views in FIGS. 82 and 83, the bodies 502 and506 are opposing bodies, each having a positive pole 512 and a negativepole 514, with bodies 502 and 506 positioned within the upper plane ofthe housing 510, each having a positive pole 512 on their upper surface513 and a negative pole 514 on their lower surface 509. The bodies 504,508 comprise bodies which are smaller in dimension and include apositive pole 512 on their lower most surface 509 and a negative pole514 on their upper surface 513. In effect, each magnetic body containsboth a positive and negative pole. This particular arrangement of polesprovides the desired quadripolar configuration. The magnetic fields of502, 506, 504, 508 will combine symmetrically in three dimensions in thespace above the magnets according to the size and magnetization of themagnets.

Turning next to the implementation illustrated in FIGS. 4 through 6,again there is provided four magnetic bodies set fixed within housing510. However, in this implementation, there is provided two smallmagnetic bodies 518, 520, oriented such that there is a negative pole514 on the upper surface, each having the negative pole 514 on theirupper surface 513, and a positive pole 512 on their lower surface 509.In this implementation there is also provided an opposing pair of largermagnetic bodies 522, 524 positioned at an angle within housing 510, andopposing one another, each body 522, 524 having a positive pole 512 ontheir upper surfaces 513, and a negative pole 514 on their lowersurfaces 509. As seen in FIG. 4, the position of the bodies within thehousing in this fashion allows the combined magnetic field to be focusedat point 525, as illustrated by phantom lines 526. The positioning themagnetic bodies in this alignment maintains the quadripolarconfiguration of the magnets that allows control over the steep magnetfield gradient.

In FIGS. 7 through 10, the magnetic bodies 502 through 508 are chargedsimilarly as the bodies described in FIGS. 1 through 3, and arepositioned within housing 510 in the identical fashion. However, in theimplementation provided in FIGS. 7 through 10, each of the bodies arecontained within a wire coil 528, wound tightly around each of thebodies, with the coil having a positive pole 512 and negative pole 514,through which an electrical current could be run during use. Theelectric field is an alternating current and creates an electromagneticfield. The wire coils behave the same as permanent magnets as long asthe current is flowing.

In FIGS. 11 through 13, the magnetic device 500 contains four chargedmagnetic bodies 502, 504, 506, 508, each being of identical size, withbodies 502 and 506 being positively charged while bodies 504 and 508 arenegatively charged, each being positioned opposite one another. In thisimplementation, rather than have a solid fill between the magneticbodies within housing 510, the fill (fluid volume 530 illustrated inFIG. 13) may be of the type of gel which was described earlier

Those skilled in the art will understand that the magnetization of thefour magnets need not be identical. Magnetization of a positive pair tobe different than a negative pair creates a magnetic field in spacewhose magnitude and position is controlled by the magnetization of thepairs. Magnetic material of a wide range of magnetization iscommercially available to construct such magnets.

In FIGS. 14 through 19, the magnetic device 500, includes four magneticbodies 502, 504, 506, 508, each oppositely charged positively andnegatively, as with the previous implementations and contained and fixedwithin housing 510. FIG. 16 shows a side view of magnets 502 and 506from FIG. 14 and FIG. 17 shows the side view of magnets 504 and 508illustrating that they may be of different sizes within the housing 510.FIG. 15 shows the presence of a flux focusing ring which returns themagnetic field. All of the figures on this page were intended to relateto the electromagnets and to show that they can be on different size andto show wires coming out of them that can be attached to the AC circuit.FIGS. 8-10 do not show any wires to the outside circuit and only showthe toroid. The rest are intended to show that electromagnets can be ofcylindrical shape with various aspect ratios.

To further illustrate the disclosure described herein, some specificexamples are provided as follows. The apparatus described in U.S. Pat.No. 5,312,321 has the geometry as depicted in FIG. 20.

In FIG. 20, the magnets are all the same size and strength. Measurementsmade of the field strength showed that the largest gradient, which iscalculated, occurred along the line from the North to the South Pole inthis configuration. There are four points at which the maximum canoccur. FIG. 21 shows the magnitude of the magnetic field along the linefrom a North Pole to a South Pole.

The line in the FIG. 21 is calculated but the points along the lineagreed with the measured points within the limitations of the Guassmeterprobe (about 0.5 mm). The field gradient is the derivative of this curveand it is a negative number when the curve is decreasing and a positivenumber when the curve is increasing. The gradient curve for the datapoints presented in FIG. 21 is given below in FIG. 22.

As shown in FIG. 22, the gradient was largest at a point half waybetween the North Pole and the South Pole. The magnitude of the gradientwas slightly below 10 mT per mm. The sign of the gradient indicates thedirection while the magnitude indicates the effect on the chargedparticle.

The magnetic array depicted in FIG. 23 used two different size magnetswhich could also have different magnetization values. The magnets usedin FIG. 20 were discs 12 mm in diameter and 5 mm in height. The magnetsin FIG. 20 had a residual magnetization of 500 mT. In FIG. 23, the NorthPole facing magnets are the same size, that is, 12 mm diameter and 5 mmheight. The South Pole facing magnets in FIG. 23 were smaller (8 mm indiameter by 5 mm in height) with a residual magnetization of 1200 mT.The field along the line of a North Pole to a South Pole changed to thatshown in FIG. 22. The line has been shortened to approximately 10 mm asone of the magnets in each pair was smaller. The line is not uniformlysmooth but exhibited a plateau at about 1.5 mm from the North Pole andthen it resumed the downward trend. The calculated gradient for theconfiguration in FIG. 23 is shown in FIG. 24.

As seen in FIG. 25, the magnitude of the gradient was larger than thegradient found in FIG. 23; i.e., 13 mT/mm compared to less than 10mT/mm. The maximum value occurred closer to the South Pole allowing oneto position that point in space.

FIG. 23 is only one example of possible variation in shape and designthat may be utilized to provide the maximum gradient. The various shapesallows one to tailor a pattern that is specific to the range of specificneuron locations, for example, pain that runs along a lateral section oftissue would benefit from a channel configuration than a squareconfiguration as in FIG. 20. There are a large variety of ‘custom’ fieldshapes that can be created with the designs as disclosed. These customdesigns allow one to fit the apparatus to various location on a mammalor to focus the gradient at different depths in three dimensional space.

These designs with varying and different shapes allow obtaining themaximum gradient for a particular application. In FIG. 20 there are fourplaces that are exactly at the four corners between each N-S pair. InFIG. 23, there are four points but as can be seen they are closer to theS facing poles in all four cases creating a rectangular pattern, andthus allowing a channel of greater field gradients. In thisimplementation, the quadrilateral of maximum gradient is not limited toa single plane and to a single square shape.

Pain Applications A. Pain and Swelling and Wound Healing

1. Acute Pain and Edema

In an exemplary implementation, a device that alters nerve cell behaviorin a manner that reduces painful sensations is provided.

An exemplary implementation provides an apparatus for applying asymmetric quadripolar, three dimensional magnetic flux field which isfocused and balanced to the mammal body to stabilize excitable membranesand thereby reduce pain and edema associated with acute injury,inflammation or surgical procedure and to decrease wound healing time.

A further implementation is to provide a specialized magnetic flux fieldto control and reverse the swelling associated with acute injury,inflammation and surgery.

In yet another implementation provide a method for applying atherapeutic magnetic device to the human body to relieve pain, improveblood flow, decrease healing time, and reduce swelling associated withinjury, surgery or acute inflammation.

2. Chronic Pain

In another implementation a device that alters nerve cell behavior incases of chronic pain to block the spontaneous repetitive firing of thechronically malfunctioning pain fiber (for example, A-fibers andC-fibers).

A further implementation provides an apparatus for applying a symmetric,quadripolar, three dimensional magnetic flux field which is focused andbalanced to the mammal body to stabilize excitable membranes and therebyreduce pain associated with the spontaneous repetitive firing ofchronically malfunctioning polymodal nociceptors (afferent C-fibers andA8 fibers).

Another implementation is to provide a specialized magnetic flux fieldto control and speed healing of chronic slow healing wounds.

In accordance with the principles of an exemplary implementation and asbroadly described herein, a therapeutic static magnetic treatment deviceadapted for placement against the bodies of living animals is provided.The device comprises a plurality of static magnetic bodies having atleast two positive and two negative magnetic poles in a single ormultiple planes, the magnetic poles being oriented to define the fourvertices of a three dimensional quadrilateral shape, the two positivepoles defining opposite diagonal vertices and the two negative polesdefining opposite diagonal vertices of the quadrilateral shape. Each ofthe magnetic poles being magnetically attracted by the two oppositelycharged poles and being magnetically repelled by the like charged poles.

Pain and Edema Sustained in Minor Burns, Insect Bites, Bee Stings andMinor Cuts and Abrasions

In another implementation, magnetic devices for therapeutic applicationto mammal body, and more particularly to a small reusable, multiplethree dimensional quadripolar treatment device optionally contained in asmall sterile bandage for placement on the mammal body for control ofpain and edema sustained in minor burns, insect bites, bee stings andminor cuts and abrasions.

In one implementation the apparatus provides a magnetic device thatalters the permeability of the ion channels in membranes to the flow ofsodium and calcium and thereby stabilizing the spontaneous firing ofdamaged nerve endings as well as restores the physical integrity of themembranes and stopping the abnormal loss of cellular fluid (edema).

Minor burns, insect bites, bee stings and minor cuts and abrasions arethe most common injuries in our society, yet they are among the mostpainful and annoying injuries in our society. The only treatment formass use is cleansing, antibiotic ointment and clean bandage.

There is a great need for a bandage which will provide a sterile coverfor such wounds as well as to acutely control pain, swelling and topromote healing.

Accordingly, in a further implementation a device is provided that issmall enough to be contained in a small sterile bandage inexpensiveenough to be disposable and that alters pain fiber firing, repairsmembrane integrity, controls edema in the area of the injury andpromotes healing.

C. Foot Pain and Discomfort

Another implementation relates to magnetic devices for therapeuticapplication to the mammals, and more particularly to a three dimensionalquadripolar static magnetic device adapted for the utilization in thesoles of shoes.

In a further implementation the containment means for the magneticdevice be made of a flexible material so that placement in a shoe solewill not restrict flexibility.

In one implementation, at least one therapeutic permanent magnet deviceis embedded in a shoe. One permanent magnet device is embedded in theheel of the shoe sole while a second device is embedded in the portionof the shoe sole corresponding to the ball of the foot. The shoe intowhich the magnetic treatment devices are embedded may be of any type offootwear, as for example, running shoes, nurse's shoes or work boots.

D. Cumulative Trauma Disorder

In another implementation, a device is provided that alters nerve cellbehavior in cases of chronic pain to block the spontaneous repetitivefiring of the chronically inflamed, edematous, malfunctioning painfibers in chronic trauma disorders such as Carpel Tunnel Syndrome.

In yet another implementation, an apparatus for applying a symmetric,quadripolar, three dimensional magnetic flux field which is focused andbalanced to the mammal body to stabilize excitable membranes and therebyreduce pain associated with the spontaneous pacemaker firing ofchronically traumatized and malfunctioning polymodal nociceptors isprovided.

Another implementation provides a specialized magnetic flux field toremove edema and control pain in a chronically traumatized tissue.

It will be apparent to those of ordinary skill in the art that theapparatus of this disclosure alters C-fibers firing both in vitro and invivo.

In yet another implementation, the apparatus provides four staticmagnetic poles of alternating polarity that provides the superpositionof the four magnetic fields such that the resultant steep field gradientis perpendicular to the site of action (membrane or neurons) and is ofat least 1.5 mT.

This application further reveals a method and technique for placement ofthe devices over areas of chronic trauma such that they will alter nervecell behavior in cases of chronic pain to block the spontaneouspacemaker firing of the chronically traumatized, enflamed, edematous,malfunctioning, pain fiber in chronic trauma disorders such as CarpelTunnel Syndrome.

Additional implementations and advantages of the present disclosure willbe set forth in part in the description that follows.

E. Control of Edema and Pain as well as Speed Healing Following SurgicalProcedures and Speed Healing Rates of Chronic Slow Healing Wounds

This application further reveals a method and technique for placement ofthe disclosure on post operative incisional sites for the benefit ofpain control, edema control and increased healing rates.

In one implementation there is an apparatus for applying a symmetricquadripolar, three dimensional magnetic flux field which is focused andbalanced to the mammal body to stabilize excitable membranes and therebyreduce pain and edema associated with acute injury, inflammation orsurgical procedure and to decrease wound healing time as well as speedhealing of tissue following surgical procedures and speed healing ratesof slow healing wounds.

An additional implementation teaches the method of utilizing theapparatus which provides for applying a therapeutic magnetic device tothe human body to relieve pain, improve blood flow, decrease healingtime, and reduce swelling associated with injury, surgery or acuteinflammation along with reducing or blocking swelling and speed healingfollowing surgical procedures.

There is further provided the device which provides a specializedmagnetic flux field to control and speed healing of chronic slow healingwounds.

There is further taught the methods, devices, techniques, and processeswhich relate specifically to control of edema and pain as well as speedhealing following surgical procedures and speed healing rates of chronicslow healing wounds.

There is further taught the method which provides a device that alterscell behavior in a manner that reduces pain, swelling and speeds healingfollowing operative procedures and of slow healing wounds and speedshealing.

1. Post Operative Treatment

In another exemplary implementation, a device that alters cell behaviorin a manner that reduces pain, swelling and speeds healing followingoperative procedures.

There is further taught the device which provides a specialized magneticflux field to control and reverse the swelling associated with acuteinjury, inflammation and surgery.

In yet another implementation, an apparatus for applying a symmetricquadripolar, three dimensional magnetic flux field which is focused andbalanced to the mammal body to stabilize excitable membranes and therebyreduce pain and edema as well as speed healing of tissue followingsurgical procedures is provided.

Another implementation provides a method for applying a therapeuticmagnetic device to the mammal body to relieve pain, improve blood flow,reduce or block swelling and speed healing following surgicalprocedures.

2. Chronic Slow Healing Wounds

In a further implementation, a device that alters cell behavior in amanner that reduces pain, swelling and speeds healing of slow healingwounds is provided.

An exemplary implementation provides an apparatus for applying asymmetric quadripolar, three dimensional magnetic flux field which isfocused and balanced to the mammal body to stabilize excitablemembranes, improve blood flow, relieve pain, reduce swelling and speedhealing rates of slow healing wounds.

A further implementation presents an application of the quadripolararray in a microscopic implementation contained within a housingdesigned to be placed in the epidural space and other body cavities.

F. Potentiation of Epidural Anesthesia and Epidural Analgesia

There is taught the implementation of implantable quadripolar deviceswhich contain flux focusing and flux return means or medium.

There is further taught the application of the quadripolar array in amicroscopic implementation contained in a housing designed to be placedin the epidural space and other body cavities

There is further taught the methods, devices, techniques, and processeswhich relate specifically to potentiation of epidural anesthesia andepidural analgesia.

There is further taught the methods, devices, techniques, and processeswhich specifically relates to a method for using, quadripolar, circular,center charged, energy balanced magnetic device in a four (4) magnetarray of alternating polarity in which the magnetic poles are separatedonly by a distance which will allow a magnetic sphere of influence onall adjacent poles to suppress the firing of action potentials ofmammalian sensory neurons.

There is further taught the method which provides for applying amagnetic field which is particular to this device, to a nerve cell suchthat it alters nerve behavior by deflecting the ions that cause neuronfiring by applying a steep field gradient of at least 1.5 mTperpendicular to the flow of charge.

There is further taught the method which provides applying the magneticfield to the dorsal root ganglia by placing the device in the epiduralspace adjacent to the dorsal root.

There is further taught the method which provides for the helical designof the housing so as to allow impingement of the dorsal root regardlessof the rotation of the housing.

There is further taught the method which provides for a magnetic devicewith a configuration of static magnets with a particular pole designthat, when placed close to a nerve cell, alters the nerve cell'sresponses to external electrical stimuli.

In accordance with the principles of the present disclosure as embodiedand as broadly described herein, a method for suppressing nerve cell(particularly C-fiber) action potentials is provided. According to thedisclosure, a magnetic treatment device is placed at such a distancefrom a mammalian sensory neuron that the magnetic field of the treatmentdevice reaches the sensory neuron. During such placement, and for aperiod thereafter, the nerve cell action potentials are suppressed.

The magnetic treatment devices may be comprised of four magnetic bodieshaving two positive and two negative magnetic poles in single ormultiple planes, the magnet poles being oriented to define the fourvertices of a symmetric quadrilateral shape in a three dimensionalspace, the two positive poles defining opposite diagonal vertices, andthe two negative poles defining opposite diagonal vertices of thequadrilateral shape. Containment means are provided for holding themagnetic poles of the magnetic bodies in the quadrilateral orientationwithin a housing by embedding the magnet devices in the wall of thehousing. The plurality of magnet bodies comprises four cylindricalmagnetic bodies, each having one magnetic center charge face. It isnecessary that two of the cylindrical magnetic bodies have a positivemagnetic pole on one face and two of the magnetic bodies have a negativemagnetic pole on one face, and that the two positive and two negativemagnetic poles on the magnetically charged faces of the four magnetbodies be in the quadrilateral orientation described above. Theproximity of the individual magnets within the device must bemaintained. Separation of the individual magnets or bringing the devicein close proximity to other magnets will cause interference with themagnetic field and will change the flux lines and gradient of the fieldso that the device will not effectively alter the C-fiber firing.

An exemplary implementation relates to a method for using quadripolar,circular, center charged, energy balanced magnetic devised in a four (4)magnet array of alternating polarity in which the magnetic poles areseparated only by a distance which will allow a magnetic sphere ofinfluence on all adjacent poles to suppress the firing of actionpotentials of mammalian sensory neurons. These magnetic arrays areplaced in an epidural housing. They are placed in a helical array withthe distance between magnetic clusters being 1 cm (a distance whichbreaks the sphere of influence, one cluster field to another). Thecluster is rotated about 43 degrees in succession one cluster to thenext. There is a difference in electrical potential across a cellmembrane of sensory neurons. When a neuron receives an impulsetransmitted from another nerve cell, the electrical potential differenceacross the membrane of the cell is dramatically reduced and generallyreverses. This reduction and reversal of potential is referred to as thefiring of the neurons action potential. If such action potential firingsare suppressed, the transmissions of nerve impulses are also suppressed.

Pain sensations in the human body can be a result of improper nervefunction, as when such pain is caused by inordinately excitable nervecells or by nerve cells having cell wall membranes that leak ions. Painsensations may also be caused by damaged nerve cells, as for examplenerve cells suffering from post-operative scarring or physicallyimpinged nerve cells commonly associated with degenerative disc disease.Even when nerves function properly, chronic pain sensations areinitiated through nerve cells. Thus, new ways of altering nerve cellfunction, as for example by stabilizing nerve cell wall membranes, maylead to new therapies for the treatment of pain.

Accordingly, one implementation provides a method for applying amagnetic field which is particular to this device, to a nerve cell suchthat it alters nerve behavior. This disclosure relates to a method ofapplying the magnetic field to the dorsal root ganglia by placing thedevice in the epidural space adjacent to the dorsal root.

Another implementation provides a magnetic device with a configurationof static magnets with a particular pole design that, when placed closeto a nerve cell, alters the nerve cell's responses to externalelectrical stimuli. In order to achieve the result on nerve cells, it isnecessary that the proximity of the individual magnets within the devicebe maintained such that each pole exerts a sphere of magnetic influenceon the other poles in the device. Any alteration of the proximity of themagnets one to another, with alternating polarity, will change theeffect. Any alteration in the balance and symmetry of the power of eachindividual pole with respect to the other three poles may impair theeffect upon the cell.

It will be apparent to those skilled in the art that the apparatus ofthis disclosure alters C-fiber firing both in vitro and in vivo.

G. Cardiac Dysfunction

There is taught the methods, devices, techniques, and processes whichspecifically relate to symmetric magnetic devices such that theresultant steep field gradient is perpendicular to the site of action(membrane or neurons) and is of at least 1.5 mT for therapeuticapplication to mammals and more particularly to a static permanentquadripolar treatment device for placement in proximity to a mammalheart to control angina pectoris and cardiac dysrhythmia.

There is further taught the method which provides a device that altersmyocardial behavior in a manner which stabilizes the electricalactivity, dilates myocardial arteries, protects cells from cell deathand controls chest pain which is secondary to ischemia. Anotherimplementation is to provide a magnetic device that alters myocardialbehavior in a manner which controls myocardial ischemia and chest pain.

There is further taught the method which provides a magnetic device thatalters myocardial behavior by altering sodium and calcium channelfunction such that the quadripolar, alternating polarity and thesubsequent field gradient block varying degrees of sodium and calciumchannel function. The degree of blockage is related to the gradient andstrength of the field. The gradient and the field strength may bemanipulated by this technology.

There is further taught the method which provides an apparatus forapplying a variable magnetic flux to the mammal body in the area of theheart by manipulating components, size and location of the apparatus.

Another implementation relates to magnetic devices for therapeuticapplication to the human body, and more particularly to a staticpermanent quadripolar treatment device for placement in proximity to thehuman heart to control angina pectoris (chest pain) and cardiacdysrhythmia. The three dimensional flux field gradient, when applied tothe area of the heart which controls arrhythmia, improves blood flow,controls angina and protects ischemic myocardial muscle from cell death.

Another implementation of the device is effective in control ofrefractory angina pectoris and potentiates the effects of thepharmaceuticals, especially calcium channel blockers.

Accordingly, another implementation provides a device that altersmyocardial behavior in a manner which stabilizes the electricalactivity, dilates myocardial arteries, protects cells from cell deathand controls chest pain which is secondary to ischemia. Additionalimplementation is to provide a magnetic device that alters myocardialbehavior in a manner which controls myocardial ischemia and chest pain.

In an exemplary implementation, a magnetic device that alters myocardialbehavior by altering sodium and calcium channel function such that thequadripolar, alternating polarity and the subsequent field gradientblock varying degrees of sodium and calcium channel function isprovided. The degree of blockage is related to the gradient and strengthof the field. The gradient and the field strength may be manipulated bythis technology.

Another implementation provides an apparatus for applying a variablemagnetic flux to the human body in the area of the heart by manipulatingcomponents, size and location of the apparatus.

H. Control of Pain and Sludging of Sickled Cells in Sickle Cell Disease

There is taught the methods, devices, techniques, and processes whichrelate specifically to control of pain and sludging of sickled cells insickle cell disease. Particularly a method which implements thedisclosure to alter cell behavior in a manner that reduces sickle cellsymptoms is taught.

In this implementation, a device that alters cell behavior in a mannerwhich blocks or reverses the acute sickling process which leads to lowoxygen carrying capacity and sludging of the sickled cells which causespain and infection of major organs is provided. The device of thepresent disclosure also controls the pain which is associated withsickling.

The position of the devices is dictated by the location of the pain insickle cell crisis. The device may be used prophylactically to preventsickle cell symptoms.

Seizure/Movement Control Applications

In accordance as broadly described herein, a therapeutic static magnetictreatment device is adapted for placement of each device on the head ofliving mammals providing a symmetric three dimensional magnetic fieldsuch that the resultant steep field gradient is perpendicular to thesite of action (membrane or neurons) and is of at least 1.5 mT. The 3dimensional, steep gradient field created by the disclosure effectivelystops neuronal discharge in the central nervous system and inhibits orreverses cerebral edema.

I. Seizure Control

Another implementation relates to magnetic devices for therapeuticapplication to the human body, and more particularly to a quadripolartreatment device for placement on either the outside of the human heador implantable units for control of seizure disorders.

A further implementation provides a device that alters brain neuronalbehavior in a manner which substantially stops the abnormal electricaldischarge of the neurons, therefore stopping the seizures.

In an exemplary implementation, a magnetic device that alters brainneuronal behavior in a manner which substantially stops and controlsdrug resistant seizures. Another implementation provides a method ofapplying a therapeutic magnetic device such that the resultant steepfield gradient is perpendicular to the site of action (membrane orneurons) and is of at least 1.5 mT and relieve seizure in the mammal'shead.

In a further implementation, a method of external attachment of thetherapeutic quadripolar magnetic device to the area of the head, amethod of implanting the device in the skull table and a method andapparatus for implanting the device intracerebrally is provided.

In a further implementation, the therapeutic quadripolar magnetic devicemay be implanted in the skull table or intracerebrally.

J. Treatment of Movement Disorders

An exemplary implementation relates to magnetic devices for and methodsfor therapeutic application to the human body, and more particularly toa device for application of the human head in the area of the basalganglia and/or application of a small implantable device to place in theappropriate location in the area of the basal ganglia.

In a further implementation, a device (and a method for itsapplications) which is adaptable to be applied to the skin of the heador may be implanted under stereotactic guidance into areas of the boralganglia for the control of movement disorders, the device may be usedeither alone or in combination with medication, either to augment or topotentiate the drug effects.

Delay of Cell/Tissue Decay Applications K. Protection of TransplantOrgans

There is taught the method which provides a device to better maintaincell integrity of transplantable organs by transporting them in acontainer equipped with a quadripolar magnetic flux generator whichcovers the organ with a step gradient quadripolar static magnetic fluxfield during transport.

In another implementation, a therapeutic static magnetic treatmentdevice may be adapted for placement inside a human organ transplanttransport cooler.

The current disclosure is designed to better maintain the cell integrityof the transplantable organ by transporting it in a container which isequipped with a quadripolar magnetic flux generator which covers theorgan with a steep gradient, quadripolar, static magnetic flux fieldduring transport. The field has been shown to possess the ability tooffer significant protection from cell death.

In a further implementation, the magnetic field in a transport containerfor such organs as hearts, livers, kidneys, lungs and pancreases.

A major problem for the successful transplantation of freshly harvestedorgans is time from harvesting to transplantation. The organs arechilled in saline glucose in an attempt to slow metabolism and retardcatabolism and shock of the organ. The efforts are not totallysuccessful in preserving a good quality organ for transplant. There isneed for a system which will better maintain the integrity of the organsuch that it is delivered in optimal condition to the transplantrecipient.

In exemplary implementations, the device better maintains the cellintegrity of the transplantable organ by transporting it in a containerwhich is equipped with a quadripolar magnetic flux generator whichcovers the organ with a steep gradient quadripolar static magnetic fluxfield during transport. This field has been shown to possess significantprotection from death for isolated cells and organs in the laboratory.

L. Protection from Cell Injury and Death Following Neuronal Cell Insultssuch as Contusion, Hypoxia, Stroke and Infection

This application further reveals a method and technique for placement ofthe devices on the external body area overlying neuronal tissue such asbrain, spinal cord and peripheral nerves following cell insults such ascontusion, hypoxia, stroke, bleeding and infection.

An exemplary implementation relates to magnetic devices for therapeuticapplication to the human body, and more particularly to a quadripolartreatment device for placement on the human head, spinal cord or otheraccessible nervous tissue, to protect injured or insulted cells fromcell death by providing a resultant steep field gradient that isperpendicular to the site of action (membrane or neurons) and is of atleast 1.5 mT.

M. Magnetic Treatment Device for Treatment of Neurological DeficitsIncluding Residual Encephalopathy Following Neurological Insults such asStrokes—for Protection from Cell Death and Dysfunction Following HypoxicInjuries

There is taught the methods, devices, techniques, and processes whichrelate specifically to protection from cell injury and death followingneuronal cell insults such as contusion, hypoxia, stroke and infection.Also taught is application to the human body, and more particularly to aquadripolar treatment device for placement on the human head, spinalcord or other accessible nervous tissue, to protect injured or insultedcells from cell death.

An exemplary implementation relates to magnetic devices for therapeuticapplication to the human body and more particularly to a magnetic skullcap which utilizes appropriately placed quadripolar devices of thedisclosure for placement on the human head for the application ofseveral quadrilateral, steep, three dimensional magnetic flux steepfield gradient devices.

An additional implementation of this disclosure is to provide neuroprotection with the magnetic device as described both alone and toaugment other agents such as drugs and hyperbaric oxygen both in humansand animal modles.

It is a further purpose of this disclosure to bring about protectionfrom cell death, reduction of edema and reactivation of live but poorlyfunctioning neuronal tissue in intra-cranial hemorrhage, strokes,hypoxic ischemicencephalopathy, brain contusions, encephalits, radiationtherapy and spinal cord injuries.

A further implementation of this disclosure brings about protection fromvasospastic phenomenon secondary to sub arachnoids hemorrhage. Thevasospams results in delayed cerebral ischemia. A skull cap containingthe symmetric three dimensional magnet with the steep field gradientthat is perpendicular to the site of action (membrane or neurons) and isof at least 1.5 mT of this disclosure generates a magnetic flux fieldwhich blocks the vasospastic phenomenon.

Diagnostic Applications

1. Local Pain

Local pain is generated in the receptor field of the C-fibers whichconduct painful impulses into the dorsal root entry zone and to highercenters where the impulse is interpreted as pain. C-fiber sympatheticefferent fibers are activated at the cord level and these fibersinnervate the receptor field where the pain originates. These C-fiberefferents sensitize the somatic afferents. This sympathetic C-fiberefferent discharge into the receptor field brings about an increase ofelectrolyte and therefore increases the tissue conductance and decreasesthe resistance. This increased conductance in the skin, if properlyinterpreted, will allow the practitioners to determine the mosteffective locations for the quadripolar magnetic flux generator to beplaced. When the magnetic flux generator of the disclosure is placedover the area of maximum conductance in a receptor field whichcorresponds to the local pain pattern, the C-fiber discharge issuppressed. Therefore, pain fiber impulse is blocked distally. In anexemplary implementation, once the area of maximum conductance islocated, a second head will be rotated into place against the skin. Thishead will contain a quadripolar, alternating pole steep gradientmagnetic flux generator and wiring means to stimulate electrically andmagnetically. The magnetic gradient suppresses C-fiber firing and theelectrical stimulator activates A-fiber firing in order to give instantconfirmation of the correct location.

2. Radicular Pain

Radicular pain is generated by abnormal C-fiber discharge within thedorsal root. The symptoms are many such as compression, inflammation,hypoxia, contusion, and neuroproxia.

The dorsal division of the dorsal root is a small remnant in mammals andonly innervates a narrow strip of tissue on either side of the spinalcord. This dorsal division of the dorsal root contains sympatheticefferent fibers in addition to somatic afferents. These efferent fibersdischarge into the receptor field, thereby increasing skin conductance.Therefore, in this instance areas of increased conductance of the skinsuperficial to the root are compatible with compression, radiculitis orother malfunction of the dorsal root. In an exemplary implementation,when an area of conductance increases twice the background is located, asecond head of the device will be rotated into place against the skin.This head will contain a quadripolar, alternating pole, steep gradientmagnetic flux generator and wiring means to stimulate electrically andmagnetically the magnetic gradient suppresses C-fiber firing and theelectrical stimulator activates A-firing in order to give instantconfirmation of the correct location. The magnetic flux generator willsuppress C-fiber firing directly and thereby reduce pain. The electricalstimulator will block C-fiber input into the central nervous system inthe area of the substantiation.

Another implementation presents an electrical stimulator comprised of apulse generator, controls for controlling the pulse frequency andmorphology and an annular electrode system for both conductance readingand a second hear with an annular electrode for stimulation. Thetechnology also provides for plastic containment means.

O. Potentiation of Pharmaceuticals and Focusing the Point of MaximumTherapy by Concentrating Drug to the Active Site

An exemplary implementation relates to magnetic devices for therapeuticapplication to the human body, and more particularly to various sizedmagnetic devices for placement on the area of the human body in whichdrug potentiation is desired, such that the steep field gradientquadripolar field will interact with the drug, receptor or both.

There is taught the methods, devices, techniques, and processes whichrelate specifically to potentiation of pharmaceuticals and focusing thepoint of maximum therapy by concentrating drug to the active site.

There is further taught the methods, devices, techniques, and processeswhich relate specifically to magnetic devices for therapeuticapplication to the human body particularly to various sized magneticdevices for placement on the area of the human body in which drugpotentiation is desired, such that the steep field gradient quadripolarfield will interact with the drug and/or receptor.

There is further taught the methods which provides for potentiate thetherapeutic effects at the receptor site.

There is further taught the methods which provides for use ofmagnetically compliant drugs which are thereby concentrated at thereceptor area.

There is further taught the methods which potentiate the onset andintensity and duration of local anesthetics such as lidocaine when usedas a dermally applied gel underneath the magnetic device for the purposeof bringing about rapid local anesthesia for minor procedures.

There is further taught the methods which place an intracranialquadripolar micro implant near an irritable focus to potentiate theeffects of dilantin in the control of seizures which are drug resistant.

The use of pharmaceutical agents in medicine is at an all time high.Along with the desired effects, many drugs have significant side effects(undesirable effects) at the doses needed for the desired therapeuticeffects. Another implementation potentiates the therapeutic effects atthe receptor site, and in some instances in which magnetically compliantdrugs are involved, the technology of this disclosure will concentratethe drug at the receptor area.

In a further implementation the device potentiates the onset andintensity and duration of local anesthetics such as lidocaine when usedas a dermally applied gel underneath the magnetic device for the purposeof bringing about rapid local anesthesia for minor procedures.

In another implementation, the device is used to place an intracranialquadripolar micro implant near an irritable focus to potentiate theeffects of dilantin in the control of seizures which are drug resistant.

Other Applications

Q. Control of Nausea and Vomiting Associated with Pregnancy, Motion andChemotherapy

This application reveals a method and technique for placement of thedisclosure on the external body area over the vestibules apparatus andthe distal medial radius area for the control of nausea and vomitingassociated with pregnancy, motion and chemotherapy.

There is further taught the methods, devices, techniques, and processeswhich specifically relates to nausea and vomiting associated withpregnancy, motion and chemotherapy and also secondary to a variety ofexternal stimuli.

An exemplary implementation relates to magnetic devices for therapeuticapplication to the human body and more particularly to a static magneticquadripolar treatment device for placement on the human body such thatthe resultant steep field gradient is perpendicular to the site ofaction (membrane or neurons) and is of at least 1.5 mT for control ofnausea and/or vomiting associated with pregnancy, motion sickness andchemotherapy.

While this disclosure has been described with emphasis on selectedimplementations, it should be understood that within the scope of theappended claims, the disclosure might be practiced or carried out invarious ways other than as specifically described herein. In addition,many modifications may be made to adapt a particular situation,material, composition of matter, method, process step or steps, to theobjective, spirit and scope of the present disclosure. All suchmodifications are intended to be within the scope of the claims appendedhereto. In particular, while the methods disclosed herein have beendescribed with reference to particular steps performed in a particularorder, it will be understood that these steps may be combined,sub-divided, or re-ordered to form an equivalent method withoutdeparting from the teachings of the present disclosure. Accordingly,unless specifically indicated herein, the order and grouping of thesteps is not a limitation of the present disclosure. The foregoingdescription illustrates and describes the processes, machines,manufactures, compositions of matter, and other teachings of the presentdisclosure. Additionally, the disclosure shows and describes onlycertain embodiments of the processes, machines, manufactures,compositions of matter, and other teachings disclosed, but, as mentionedabove, it is to be understood that the teachings of the presentdisclosure are capable of use in various other combinations,modifications, and environments and is capable of changes ormodifications within the scope of the teachings as expressed herein,commensurate with the skill and/or knowledge of a person having ordinaryskill in the relevant art. The embodiments described hereinabove arefurther intended to explain certain best modes known of practicing theprocesses, machines, manufactures, compositions of matter, and otherteachings of the present disclosure and to enable others skilled in theart to utilize the teachings of the present disclosure in such, orother, embodiments and with the various modifications required by theparticular applications or uses. Accordingly, the processes, machines,manufactures, compositions of matter, and other teachings of the presentdisclosure are not intended to limit the exact embodiments and examplesdisclosed herein.

1. A method for altering the charge distribution upon a living membranewith functional stabilization of the membrane physical electricalintegrity, comprising: (a) providing a magnetic device in a four (4)magnet array of alternating polarity in which the magnetic poles areseparated by a predetermined distance to provide an effective3-dimensional symmetric magnetic sphere of influence at the desired siteof action from the vector sum of all magnetic fields of all adjacentpoles; and (b) positioning the device adjacent the living membrane tosuppress the firing of action potentials of mammalian sensory neurons;wherein the magnet array is designed to focus the magnetic sphere atdifferent depths due to the size, orientation or shape of the magnets.2. The method of claim 1 wherein the magnets are varying in size toalter the location of the gradient of the magnetic field to set thesteepest magnitude of the gradient at the sensory neuron.
 3. The methodof claim 1 wherein the magnets are oriented to focus the magnetic fieldat a single point to alter the location of the gradient of the magneticfield at the sensory neuron.
 4. The method of claim 1 wherein said3-dimensional symmetric magnetic field is at least 1.5 mT at the site ofthe neurons.
 5. The method of claim 1 further comprising the step ofproviding a conductive fluid flux focusing medium above and around themagnetic array to focus the magnetic field at the site of the membranescontaining neurons.
 6. The method of claim 1, further comprising thestep of providing a non-conductive fluid flux return medium below themagnetic array to allow the magnetic field to penetrate to the site ofthe membrane to be treated.
 7. The method of claim 6, wherein the fluxfocusing medium may comprise a flux focusing ring or other medium andthe flux return medium may comprise a flux return ring or other mediumwherein said flux return ring returns at least 50% of magnetic field tomembrane site containing neurons.
 8. The method of claim 1 furthercomprising the step of providing a steep field gradient from the magnetarray of alternating polarity at the site of the neurons.
 9. The methodof claim 8 wherein said steep field gradient from said magnet array isperpendicular to the direction of neuron current flow.
 10. The method ofclaim 1, wherein the method is utilized in the treatment of at least oneof a disease, disorder, complication and condition.
 11. The method ofclaim 10 wherein said disease, disorder, complication and condition isselected from the group consisting of acute and chronic pain, cardiacdisorders, potentiation of pharmaceuticals, movement disorders,potentiation of anesthesia, nausea control, and trauma.
 12. The methodof claim 1, wherein the magnets are replaced by electromagnets whereinthe magnetic field is obtained by providing an alternating currentthrough wires that are wrapped into a coil.
 13. The method of claim 1further comprising applying a symmetric quadripolar, three dimensionalmagnetic flux field which is focused and balanced to the human body tostabilize excitable membranes and thereby reduce pain and edemaassociated with acute injury, inflammation or surgical procedure and todecrease wound healing time wherein the field gradient is steep and atleast 1.5 mT at the site of the neurons.
 14. A method for altering thecharge distribution upon a living membrane with functional stabilizationof the membrane physical electrical integrity, comprising: (a) providinga morphologically adaptable magnetic device in a four (4) magnet arrayof alternating polarity in which the magnetic poles are positioned atdiffering planes to provide an effective 3-dimensional symmetricmagnetic sphere of influence at the desired site of action from thevector sum of all magnetic fields of all adjacent poles; and (b)positioning the device adjacent the living membrane to suppress thefiring of action potentials of mammalian sensory neurons.
 15. The methodof claim 14, further comprising the step of providing a conductive fluidflux focusing medium above and around the magnetic array to focus themagnetic field at the site of the membranes.
 16. The method of claim 14,further comprising the step of providing a non-conductive fluid fluxreturn medium below the magnetic array to allow the magnetic field topenetrate the site of the membranes to be treated.
 17. The method ofclaim 16, wherein the flux focusing medium may comprise a flux focusingring or other medium and the flux return medium may comprise a fluxreturn ring or other medium wherein said flux return ring returns atleast 50% of magnetic field to membrane site containing neurons.
 18. Themethod of claim 14 wherein said 3-dimensional symmetric magnetic sphereis at least 1.5 mT at the site of the neurons.
 19. The method of claim14 further comprising the step of providing a steep field gradient fromthe magnet array of alternating polarity at the site of the neurons. 20.The method of claim 19 wherein said steep field gradient from saidmagnet array is perpendicular to the direction of neuron current flow.21. The method of claim 14 wherein the method is utilized in thetreatment of at least one of a disease, disorder, complication andcondition.
 22. The method of claim 21 wherein said disease, disorder,complication and condition is selected from the group consisting ofacute and chronic pain, cardiac disorders, potentiation ofpharmaceuticals, movement disorders, potentiation of anesthesia, nauseacontrol, and trauma.
 23. The method of claim 14, wherein the magnets arereplaced by electromagnets, wherein the magnetic field is obtained byproviding an alternating current through wires that are wrapped into acoil.
 24. The method of claim 14 further providing the step of applyinga symmetric quadripolar, three dimensional magnetic flux field which isfocused and balanced to the human body to stabilize excitable membranesand thereby reduce pain and edema associated with acute injury,inflammation or surgical procedure and to decrease wound healing timewherein the field gradient is steep and at least 1.5 mT at the site ofthe neurons.
 25. A method for altering the charge distribution upon aliving membrane with functional stabilization of the membrane physicalelectrical integrity, comprising: (a) providing a morphologicallyadaptable apparatus comprising a quadrupolar magnetic device in a fourmagnet array of alternating polarity in which the magnetic poles of themagnets are laterally separated by a predetermined distance to providean effective magnetic sphere of influence focused at the desired site ofaction from the magnetic fields of all adjacent poles to suppress thefiring of action potentials of mammalian sensory neurons, wherein thediagonally opposite magnets of the magnet array are disposed onrespective first and second planes to alter the focus of the magneticsphere at different depths and provide at least 1.5 mT at the receptorneurons in a group of cells producing pain signals; and (b) positioningthe apparatus adjacent the living membrane to suppress the firing ofaction potentials of mammalian sensory neurons.